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1.
Yonsei Med J ; 62(2): 177-181, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33527798

RESUMO

We sought to analyze the efficacy of adalimumab in active noninfectious uveitis, and evaluate its efficacy and safety for the management of refractory noninfectious uveitis in Korean patients. A retrospective observational study was conducted. A total of 23 eyes of 14 Korean patients with noninfectious uveitis refractory to conventional treatment, including corticosteroid and immunosuppressive agents, were treated with adalimumab between December 2017 and February 2020. The primary outcomes were vitreous haziness grades, anterior chamber cell grades, and central macular thickness measured prior to injection and at 1, 3, 6, and 12 months after the first adalimumab injection. Among the 23 eyes, 14 eyes (60.9%) were diagnosed with panuveitis and 9 eyes (39.1%) with posterior uveitis [mean follow-up period: 22.3 months (7-27)]. The most common etiologic diagnoses requiring adalimumab injection were Behçet's disease (9 eyes, 39.1%), followed by undifferentiated inflammation (6 eyes, 26.1%), Vogt-Koyanagi-Harada disease (3 eyes, 13.0%), psoriasis (2 eyes, 8.7%), serpiginous chorioretinopathy (2 eyes, 8.7%), and systemic lupus erythematosus (1 eye, 4.3%). At the 1-year follow-up after the first injection, anterior chamber cell grade decreased from 0.5±0.4 to 0.3±0.4, and vitreous haziness grade decreased from 1.1±1.1 to 0.3±0.5 (p<0.05). Central macular thickness improved from 347.2±98.1 µm to 264.3±61.1 µm (p<0.05). Adalimumab injection in patients with refractory noninfectious uveitis decreased the anterior chamber cell grade, vitreous haziness grade, and central macular thickness with no severe side effect. Overall, adalimumab injection may, therefore, be an effective and relatively safe treatment modality for noninfectious uveitis in Korean patients.


Assuntos
Adalimumab/uso terapêutico , Uveíte/tratamento farmacológico , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adolescente , Adulto , Feminino , Humanos , Imunossupressores/farmacologia , Imunossupressores/uso terapêutico , Masculino , Pessoa de Meia-Idade , República da Coreia , Estudos Retrospectivos , Resultado do Tratamento , Uveíte/diagnóstico , Uveíte/fisiopatologia , Acuidade Visual/efeitos dos fármacos , Adulto Jovem
4.
Cochrane Database Syst Rev ; 8: CD012328, 2020 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-32746500

RESUMO

BACKGROUND: About half of patients with Crohn's disease (CD) require surgery within 10 years of diagnosis. Resection of the affected segment is highly effective, however the majority of patients experience clinical recurrence after surgery. Most of these patients have asymptomatic endoscopic recurrence weeks or months before starting with symptoms. This inflammation can be detected by colonoscopy and is a good predictor of poor prognosis.Therapy guided by colonoscopy could tailor the management and improve the prognosis of postoperative CD. OBJECTIVES: To assess the effects of prophylactic therapy guided by colonoscopy in reducing the postoperative recurrence of CD in adults. SEARCH METHODS: The following electronic databases were searched up to 17 December 2019: MEDLINE, Embase, CENTRAL, Clinical Trials.gov, WHO Trial Registry and Cochrane IBD specialized register. Reference lists of included articles, as well as conference proceedings were handsearched. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-RCTs and cohort studies comparing colonoscopy-guided management versus management non-guided by colonoscopy. DATA COLLECTION AND ANALYSIS: Two review authors independently considered studies for eligibility, extracted the data and assessed study quality. Methodological quality was assessed using both the Cochrane 'Risk of bias' tool for RCTs and Newcastle-Ottawa scale (NOS) for cohort studies. The primary outcome was clinical recurrence. Secondary outcomes included: endoscopic, surgical recurrence and adverse events. We calculated the risk ratio (RR) for each dichotomous outcome and extracted the hazard ratio (HR) for time-to-event outcomes. All estimates were reported with their corresponding 95% confidence interval (CI). Data were analysed on an intention-to-treat (ITT) basis. The overall quality of the evidence was evaluated using GRADE criteria. MAIN RESULTS: Two RCTs (237 participants) and five cohort studies (794 participants) met the inclusion criteria. Meta-analysis was not conducted as the studies were highly heterogeneous. We included two comparisons. Intensification of prophylactic-therapy guided by colonoscopy versus intensification guided by clinical recurrence One unblinded RCT and four retrospective cohort studies addressed this comparison. All participants received the same prophylactic therapy immediately after surgery. In the colonoscopy-based management group the therapy was intensified in case of endoscopic recurrence; in the control group the therapy was intensified only in case of symptoms. In the RCT, clinical recurrence (defined as Crohn's Disease Activity Index (CDAI) > 150 points) in the colonoscopy-based management group was 37.7% (46/122) compared to 46.1% (21/52) in the control group at 18 months' follow up (RR 0.82, 95% CI: 0.56 to 1.18, 174 participants, low-certainty evidence). There may be a reduction in endoscopic recurrence at 18 months with colonoscopy-based management (RR 0.73, 95% CI 0.56 to 0.95, 1 RCT, 174 participants, low-certainty evidence). The certainty of the evidence for surgical recurrence was very low, due to only four cohort studies with inconsistent results reporting this outcome. Adverse events at 18 months were similar in both groups, with 82% in the intervention group (100/122) and 86.5% in the control group (45/52) (RR 0.95, 95% CI:0.83 to 1.08, 1 RCT, 174 participants, low-certainty of evidence).The most common adverse events reported were alopecia, wound infection, sensory symptoms, systemic lupus, vasculitis and severe injection site reaction. Perforations or haemorrhages secondary to colonoscopy were not reported. Initiation of prophylactic-therapy guided by colonoscopy versus initiation immediately after surgery An unblinded RCT and two retrospective cohort studies addressed this comparison. The control group received prophylactic therapy immediately after surgery, and in the colonoscopy-based management group the therapy was delayed up to detection of endoscopic recurrence. The effects on clinical and endoscopic recurrence are uncertain (clinical recurrence until week 102: RR 1.16, 95% CI 0.73 to 1.84; endoscopic recurrence at week 102: RR 1.16, 95% CI 0.73 to 1.84; 1 RCT, 63 participants, very low-certainty evidence). Results from one cohort study were similarly uncertain (median follow-up 32 months, 199 participants). The effects on surgical recurrence at a median follow-up of 50 to 55 months were also uncertain in one cohort study (RR 0.79, 95% CI 0.38 to 1.62, 133 participants, very low-certainty evidence). There were fewer adverse events with colonoscopy-based management (54.8% (17/31)) compared with the control group (93.8% (30/32)) but the evidence is very uncertain (RR 0.58, 95% CI 0.42 to 0.82; 1 RCT, 63 participants). Common adverse events were infections, gastrointestinal intolerance, leukopenia, pancreatitis and skin lesions. Perforations or haemorrhages secondary to colonoscopy were not reported. AUTHORS' CONCLUSIONS: Intensification of prophylactic-therapy guided by colonoscopy may reduce clinical and endoscopic postoperative recurrence of CD compared to intensification guided by symptoms, and there may be little or no difference in adverse effects. We are uncertain whether initiation of therapy guided by colonoscopy impacts postoperative recurrence and adverse events when compared to initiation immediately after surgery, as the certainty of the evidence is very low. Further studies are necessary to improve the certainty of the evidence of this review.


Assuntos
Colonoscopia , Doença de Crohn/prevenção & controle , Doença de Crohn/cirurgia , Prevenção Secundária/métodos , Adalimumab/efeitos adversos , Adalimumab/uso terapêutico , Adulto , Antibacterianos/uso terapêutico , Anti-Inflamatórios não Esteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/uso terapêutico , Doenças Assintomáticas , Azatioprina/efeitos adversos , Azatioprina/uso terapêutico , Viés , Estudos de Coortes , Doença de Crohn/diagnóstico por imagem , Humanos , Imunossupressores/efeitos adversos , Imunossupressores/uso terapêutico , Mesalamina/efeitos adversos , Mesalamina/uso terapêutico , Metronidazol/efeitos adversos , Metronidazol/uso terapêutico , Purinas/efeitos adversos , Purinas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Estudos Retrospectivos , Fator de Necrose Tumoral alfa/antagonistas & inibidores
5.
Brasília; CONITEC; ago. 2020.
Não convencional em Português | BRISA/RedTESA | ID: biblio-1121414

RESUMO

Introdução: A psoriase e uma doenca inflamatoria sistemica cronica com manifestacoes frequentemente cutaneas, ungueais e articulares, cursando normalmente de forma remitente e recorrente. Com distribuicao similar entre os sexos e ocorrencia mais frequente entre a terceira e quarta decadas de vida, sua prevalencia no Brasil e estimada entre 1,31% a 2,5%. No SUS, os pacientes possuem garantia de acesso aos tratamentos preconizados em diretrizes terapeuticas, onde o tratamento e iniciado com farmacos por via topica, seguidos de outras opcoes como a fototerapia, medicamentos por via oral e injetaveis de acordo com a gravidade. Os fármacos sistemicos indicados em primeira linha incluem o metotrexato, acitretina e ciclosporina. Em caso de falha destes medicamentos, estao disponiveis outros, quatro biologicos, sendo dois da classe dos anti-TNF (adalimumabe e etanercepte) e dois medicamentos anti-interleucinas, um da classe dos anti-IL12/23 (ustequinumabe) e outro da classe dos anti-IL17 (secuquinumabe). PERGUNTA: O uso de ixequizumabe e eficaz, seguro e custo-efetivo para a segunda etapa de tratamento biologico de pacientes adultos com psoriase em placas moderada a grave, quando comparado as terapias sistemicas biologicas aprovadas pela Conitec nessa etapa de tratamento (ustequinumabe e secuquinumabe)? TECNOLOGIA: Ixequizumabe. EVIDÊNCIAS CIENTÍFICAS: Com uso de meta-analise em rede, uma revisao sistematica da Colaboracao Cochrane teve o objetivo de comparar e hierarquizar os agentes sistêmicos convencionais e biologicos para pacientes com psoriase moderada a grave de acordo com sua eficacia e seguranca. Apos buscas amplas, a revisao incluiu 140 estudos avaliando 19 diferentes tratamentos com um total de 51.749 participantes randomizados e idade media de 45 anos. Todos os resultados (exceto dois estudos) foram limitados a fase de inducao (de 8 a 24 semanas apos a randomizacao). Problemas com o cegamento dos pacientes e envolvidos (performance) e dos avaliadores foram os riscos mais frequentemente identificados. Dentre outros riscos, ressalta-se que a maioria dos estudos declarou financiamento por uma empresa farmaceutica e 22 estudos nao relataram a fonte de financiamento. No desfecho de PASI 90, o resultado da meta-analise em rede destaca que ambos os medicamentos anti-IL17 (ixequizumabe e secuquinumabe) foram significativamente mais efetivos que o ustequinumabe e o adalimumabe. No desfecho do PASI 75 a classe de medicamentos anti-IL17 tambem foi associada a uma maior probabilidade de atingi-lo em comparacao as outras classes. Em relação ao desfecho de eventos adversos graves (EAG), os medicamentos infliximabe, ixequizumabe e secuquinumabe apresentaram maior risco de EAG do que o metotrexato. Associacoes estatisticamente significativas foram encontradas demonstrando que os anti-IL17 apresentam maior risco de eventos adversos em geral em comparacao aos anti-IL23 e anti-IL12/23. O nível de certeza das evidencias de efetividade do ixequizumabe foi considerado moderado (com reducoes devido a inconsistencias) e no desfecho de eventos adversos graves foi considerado moderado (com reducoes devido a imprecisao). AVALIAÇÃO ECONÔMICA: Considerando que a "analise de custo por resposta" enviada pelo demandante carece do rigor metodologico das avaliacoes economicas completas, foi elaborado um novo modelo de custo-efetividade contemplando todas as opcoes disponiveis no SUS e em analise pela Conitec para o tratamento da psoriase moderada a grave. Seguindo a proposta do modelo bastante difundido e concebido por pesquisadores da Universidade de York, foi construido um modelo de arvore de decisao (periodo de inducao) acoplado a um modelo de Markov (periodo de manutencao), buscando analisar os custos e consequencias em termos de anos de vida ajustados pela qualidade (QALY) com as seguintes estrategias de tratamento: ixequizumabe; secuquinumabe; ustequinumabe; risanquizumabe; adalimumabe e infliximabe. Com os resultados do modelo, a partir da analise da fronteira de eficiencia, observa-se a dominancia (efetividade menor e maior custo) dos tratamentos com infliximabe (dominância simples) e secuquinumabe (dominancia estendida) pelos tratamentos com adalimumabe, ustequinumabe e ixequizumabe. O tratamento com risanquizumabe apresenta um valor de efetividade limitrofe com o ixequizumabe, contudo, a um custo muito superior. Ao realizar a analise de limiar por meio da abordagem da fronteira de eficiencia, observa-se que seria necessario que o preco dos medicamentos secuquinumabe, ixequizumabe e risanquizumabe tivessem uma reducao de preco de pelo menos 10,74%, 9,08% e 55,09%, respectivamente, para serem considerados custo-efetivos. Na curva de aceitabilidade de acordo com o escalonamento progressivo da disposicao a pagar, os tratamentos com maior probabilidade de serem custoefetivos foram o adalimumabe, seguido do ustequinumabe e, por fim, o ixequizumabe. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: O demandante encaminhou uma analise de impacto orcamentario que, apos analise critica, considerou-se um modelo adequado e coerente com discussoes anteriores na Conitec. Todavia, alguns de seus dados foram revisados e atualizados resultando em novos valores de impacto. Em sua versao original, o demandante apresentava uma economia de R$ 14.322.953,00. Contudo, apos as atualizacoes dos custos e da taxa de falha ao adalimumabe descritas, estima-se um impacto incremental de R$ 4.052.249,89 ao longo de cinco anos. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foram detectadas no horizonte sete potenciais tecnologias para pacientes adultos com psoriase moderada a grave, apos falha da primeira etapa da segunda linha de tratamento: apremislate, bimequizumabe, BMS-986165, brodalumabe, guselcumabe, miriquizumabe e piclidenoson. CONSIDERAÇÕES: A partir das estimativas de efetividade comparativa disponiveis por meio de meta-analises em rede, e possivel observar que o ixequizumabe e o secuquinumabe foramsignificativamente mais efetivos que o ustequinumabe e o adalimumabe. Em relacao a seguranca, observam-se associacoes estatisticamente significativas de que os anti-IL17 apresentam maior risco de eventos adversos em geral em comparacao aos anti-IL23 e anti- IL12/23. O nivel de certeza das evidencias de efetividade foi considerado moderado tanto nos desfechos de efetividade e seguranca para o ixequizumabe. Na curva de aceitabilidade de acordo com a disposicao a pagar, os tratamentos com maior probabilidade de serem custoefetivos foram o adalimumabe, seguido do ustequinumabe e, por fim, o ixequizumabe. Por meio de uma reducao plausivel de preco, e possivel que o ixequizumabe apresente um perfil de custoefetividade semelhante aos tratamentos mais eficientes disponiveis no SUS. Apos as atualizacoes do modelo de impacto orcamentario encaminhado, estima-se um impacto incremental de R$ 4.052.249,89 ao longo de cinco anos com a incorporacao do ixequizumabe ao SUS. RECOMENDAÇÃO PRELIMINAR: Pelo exposto, a CONITEC, em sua 85a reuniao ordinaria, no dia 04 de fevereiro de 2020, recomendou a nao incorporacao no SUS do ixequizumabe para o tratamento de pacientes adultos com psoriase moderada a grave, que tenham apresentado falha terapeutica, contraindicacao ou intolerancia ao adalimumabe. Considerou-se que, apesar do ixequizumabe estar associado a beneficios incrementais em termos de efetividade no tratamento da condicao clinica em analise, sua eficiencia (custo-efetividade) e inferior aos tratamentos ja disponiveis no SUS com base no preco proposto pelo fabricante. A materia foi disponibilizada em consulta publica. CONSULTA PÚBLICA: Foram recebidas 142 contribuicoes tecnico-cientificas e 280 contribuicoes de experiencia ou opiniao, sendo a maioria discordante da recomendacao preliminar da CONITEC. Apos analise do texto das contribuicoes, foram identificados pontos como necessidade de mais alternativas terapeuticas ou mecanismos de acao, superioridade dentre os tratamentos disponiveis, assim como foram apresentados novas propostas de preco e limitacoes da analise preliminar. O laboratorio fabricante ofereceu uma nova proposta de preco equivalente a reducao de 2,7% do preco proposto inicialmente. No modelo atualizado, apresenta-se como uma opcao mais custo-efetiva que o secuquinumabe, porem, menos custo-efetiva que o tratamento com a tecnologia também em analise risanquizumabe. Um novo modelo de impacto orcamentario tambem foi apresentado indicando uma reducao de gastos de ate R$ 37.955.681,00 ao longo dos 5 anos na ocasiao de incorporacao na mesma linha e indicacao do secuquinumabe. Apos apreciacao das contribuicoes encaminhadas pela Consulta Publica, incluindo o destaque para a superioridade em relacao ao adalimumabe e ustequinumabe, limitacoes dos modelos apresentados, experiencias profissionais e pessoais com o tratamento e as novas propostas de preco, o plenario da Conitec entendeu que nao houve argumentacao suficiente para alterar a recomendacao inicial desfavoravel a incorporacao, em relacao ao nivel de eficiencia do tratamento em analise (custo-efetividade), no contexto proposto no SUS. RECOMENDAÇÃO FINAL: Os membros da Conitec, presentes na 89a reuniao ordinaria, no dia 6 de agosto de 2020, deliberaram, por unanimidade, recomendar a nao incorporacao no SUS do ixequizumabe para o tratamento de pacientes adultos com psoriase moderada a grave, que tenham apresentado falha terapeutica, contraindicacao ou intolerancia ao adalimumabe. DECISÃO: Nao incorporar o ixequizumabe para tratamento de pacientes adultos com psoríase moderada a grave, que tenham apresentado falha terapeutica, contraindicacao ou intolerância ao adalimumabe, no ambito do Sistema Unico de Saude - SUS, conforme Portaria no 27, publicada no Diario Oficial da Uniao no 160, secao 1, pagina 117, em 20 de agosto de 2020.


Assuntos
Humanos , Psoríase/tratamento farmacológico , Interleucina-17/uso terapêutico , Adalimumab/efeitos adversos , Ustekinumab/uso terapêutico , Avaliação da Tecnologia Biomédica , Sistema Único de Saúde , Brasil , Análise Custo-Benefício/economia
6.
Acta Clin Croat ; 59(1): 161-165, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32724288

RESUMO

Biological agents are widely used in the treatment of autoimmune rheumatic disorders. We report on serious adverse events during treatment with anti-tumor necrosis factor antibody in two of our patients with juvenile idiopathic arthritis. One patient was treated with a biological agent due to juvenile idiopathic arthritis complicated by uveitis, developing miliary tuberculosis during treatment. After treatment with antituberculotics, she recovered completely. Her underlying disease is currently in remission. Another patient was treated for juvenile spondyloarthritis and developed an inflammatory process of the central nervous system with serious neurological deficits. He was treated with high-dose corticosteroids, followed by slowly tapering doses of corticosteroids. His neurological deficits improved, but are still present. Similar cases have been described previously, but there are no recommendations how to treat arthritis afterwards in such patients. We would like to emphasize the need of developing guidelines for further treatment of arthritis after the occurrence of serious adverse effects during treatment with biological agents.


Assuntos
Doenças do Sistema Nervoso Periférico , Inibidores do Fator de Necrose Tumoral , Adalimumab/efeitos adversos , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Estudos Retrospectivos , Inibidores do Fator de Necrose Tumoral/efeitos adversos , Fator de Necrose Tumoral alfa
9.
Cochrane Database Syst Rev ; 5: CD012877, 2020 May 16.
Artigo em Inglês | MEDLINE | ID: mdl-32413933

RESUMO

BACKGROUND: Conventional medications for Crohn's disease (CD) include anti-inflammatory drugs, immunosuppressants and corticosteroids. If an individual does not respond, or loses response to first-line treatments, then biologic therapies such as tumour necrosis factor-alpha (TNF-α) antagonists such as adalimumab are considered for treating CD. Maintenance of remission of CD is a clinically important goal, as disease relapse can negatively affect quality of life. OBJECTIVES: To assess the efficacy and safety of adalimumab for maintenance of remission in people with quiescent CD. SEARCH METHODS: We searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, and clinicaltrials.gov from inception to April 2019. SELECTION CRITERIA: We considered for inclusion randomized controlled trials (RCTs) comparing adalimumab to placebo or to an active comparator. DATA COLLECTION AND ANALYSIS: We analyzed data on an intention-to-treat basis. We calculated risk ratios (RRs) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The primary outcome was failure to maintain clinical remission. We define clinical remission as a Crohn's Disease Activity Index (CDAI) score of < 150. Secondary outcomes were failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs). We assessed biases using the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of evidence supporting the primary outcome. MAIN RESULTS: We included six RCTs (1158 participants). We rated four trials at low risk of bias and two trials at unclear risk of bias. All participants had moderate-to-severe CD that was in clinical remission. Four studies were placebo-controlled (1012 participants). Two studies (70 participants) compared adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine) in participants who had an ileocolic resection prior to study enrolment. Adalimumab versus placebo Fifty-nine per cent (252/430) of participants treated with adalimumab failed to maintain clinical remission at 52 to 56 weeks, compared with 86% (217/253) of participants receiving placebo (RR 0.70, 95% CI 0.64 to 0.77; 3 studies, 683 participants; high-certainty evidence). Among those who received prior TNF-α antagonist therapy, 69% (129/186) of adalimumab participants failed to maintain clinical or endoscopic response at 52 to 56 weeks, compared with 93% (108/116) of participants who received placebo (RR 0.76, 95% CI 0.68 to 0.85; 2 studies, 302 participants; moderate-certainty evidence). Fifty-one per cent (192/374) of participants who received adalimumab failed to maintain clinical remission at 24 to 26 weeks, compared with 79% (149/188) of those who received placebo (RR 0.66, 95% CI 0.52 to 0.83; 2 studies, 554 participants; moderate-certainty evidence). Eighty-seven per cent (561/643) of participants who received adalimumab reported an AE compared with 85% (315/369) of participants who received placebo (RR 1.01, 95% CI 0.94 to 1.09; 4 studies, 1012 participants; high-certainty evidence). Serious adverse events were seen in 8% (52/643) of participants who received adalimumab and 14% (53/369) of participants who received placebo (RR 0.56, 95% CI 0.39 to 0.80; 4 studies, 1012 participants; moderate-certainty evidence) and withdrawal due to AEs was reported in 7% (45/643) of adalimumab participants compared to 13% (48/369) of placebo participants (RR 0.59, 95% CI 0.38 to 0.91; 4 studies, 1012 participants; moderate-certainty evidence). Commonly-reported AEs included CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain. Adalimumab versus active comparators No studies reported failure to maintain clinical remission. One study reported on failure to maintain clinical response and endoscopic remission at 104 weeks in ileocolic resection participants who received either adalimumab, azathioprine or mesalamine as post-surgical maintenance therapy. Thirteen per cent (2/16) of adalimumab participants failed to maintain clinical response compared with 54% (19/35) of azathioprine or mesalamine participants (RR 0.23, 95% CI 0.06 to 0.87; 51 participants). Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence). One study reported on failure to maintain endoscopic response at 24 weeks in ileocolic resection participants who received either adalimumab or 6-mercaptopurine (6-MP) as post-surgical maintenance therapy. Nine per cent (1/11) of adalimumab participants failed to maintain endoscopic remission compared with 50% (4/8) of 6-MP participants (RR 0.18, 95% CI 0.02 to 1.33; 19 participants). AUTHORS' CONCLUSIONS: Adalimumab is an effective therapy for maintenance of clinical remission in people with quiescent CD. Adalimumab is also effective in those who have previously been treated with TNF-α antagonists. The effect of adalimumab in the post-surgical setting is uncertain. More research is needed in people with recent bowel surgery for CD to better determine treatment plans following surgery. Future research should continue to explore factors that influence initial and subsequent biologic selection for people with moderate-to-severe CD. Studies comparing adalimumab to other active medications are needed, to help determine the optimal maintenance therapy for CD.


Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Doença de Crohn/tratamento farmacológico , Quimioterapia de Manutenção/métodos , Adalimumab/efeitos adversos , Adolescente , Adulto , Idoso , Anti-Inflamatórios/efeitos adversos , Azatioprina/uso terapêutico , Esquema de Medicação , Humanos , Imunossupressores/uso terapêutico , Quimioterapia de Manutenção/estatística & dados numéricos , Mercaptopurina/uso terapêutico , Mesalamina/uso terapêutico , Pessoa de Meia-Idade , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto Jovem
10.
Lancet ; 395(10235): 1496-1505, 2020 05 09.
Artigo em Inglês | MEDLINE | ID: mdl-32386593

RESUMO

BACKGROUND: Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response. METHODS: This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg secukinumab was administered subcutaneously at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 48 as a pre-filled syringe. Adalimumab was administered every 2 weeks from baseline until week 50 as 40 mg per 0·4 mL citrate free subcutaneous injection. The primary outcome was the proportion of patients with at least 20% improvement in the ACR response criteria (ACR20) at week 52. Patients were analysed according to the treatment to which they were randomly assigned. Safety analyses included all safety data reported up to and including the week 52 visit for each patient who received at least one dose of study drug. The trial is registered at ClinicalTrials.gov, NCT02745080. FINDINGS: Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive secukinumab (n=426) or adalimumab (n=427). 709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50. 61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101 (24%) of 427 patients in the adalimumab group. The primary endpoint of superiority of secukinumab versus adalimumab for ACR20 response at week 52 was not met. 67% of patients in the secukinumab group achieved an ACR20 response at week 52 versus 62% of patients in the adalimumab group (OR 1·30, 95% CI 0·98-1·72; p=0·0719). The safety profiles of secukinumab and adalimumab were consistent with previous reports. Seven (2%) of 426 patients in the secukinumab group and six (1%) of 427 patients in the adalimumab group had serious infections. One death was reported in the secukinumab group due to colon cancer and was assessed as not related to the study drug by the investigator. INTERPRETATION: Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52. However, secukinumab was associated with a higher treatment retention rate than adalimumab. This study provides comparative data on two biological agents with different mechanisms of action, which could help guide clinical decision making in the management of patients with psoriatic arthritis. FUNDING: Novartis Pharma.


Assuntos
Adalimumab/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adulto , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Tomada de Decisão Clínica , Método Duplo-Cego , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Segurança , Resultado do Tratamento
11.
Isr Med Assoc J ; 22(5): 289-293, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32378820

RESUMO

BACKGROUND: Behçet's disease is a multi-systemic chronic relapsing inflammatory disease, classified among the vasculitides. The heterogeneity of clinical manifestations challenges the disease management. OBJECTIVES: To assess efficacy and safety of adalimumab in patients with active persistent Behçet's arthritis who did not respond to disease-modifying anti-rheumatic drugs and to assess the impact of treatment on the cytokine milieu. METHODS: Our cohort comprised 10 patients with active arthritis who received adalimumab in a 24-week investigator-initiated prospective open-label study. Patients who relapsed within 12 weeks following adalimumab discontinuation could enter a 3-year extension study. The patients underwent a comprehensive assessment including questionnaires and measurement of inflammatory cytokines, adalimumab serum levels, and anti-drug antibodies. RESULTS: A significant improvement was observed in arthritis, disease activity visual analogue scales, Behçet's disease current activity form, and interleukin-6 (IL-6) levels, but not in health assessment questionnaire and functional assessment of chronic illness therapy fatigue scale questionnaire. Resolution of oral and urogenital ulcers was achieved in all patients. Significant reduction of pain was reported by 40% of patients. The disease relapsed in 9 of 10 patients, within 2-6 weeks following adalimumab discontinuation. Of the 7 patients who continued the study, arthritis was resolved in 5. Two patients with high neutralizing antidrug antibodies titer relapsed. CONCLUSIONS: Adalimumab treatment achieved a significant improvement in arthritis, mucocutaneous manifestations, and IL-6 levels in all study patients but only 40% reported significant pain reduction. The arthritis relapsed in 90% of patients following adalimumab discontinuation and long-term treatment was required.


Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Artrite/tratamento farmacológico , Síndrome de Behçet/tratamento farmacológico , Adalimumab/efeitos adversos , Adulto , Anti-Inflamatórios/efeitos adversos , Artrite/sangue , Artrite/etiologia , Síndrome de Behçet/sangue , Síndrome de Behçet/complicações , Síndrome de Behçet/diagnóstico , Citocinas/sangue , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
12.
Aliment Pharmacol Ther ; 51(12): 1342-1352, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32379358

RESUMO

BACKGROUND: Virtual clinics represent a novel model of care in inflammatory bowel disease. Their effectiveness in promoting high quality use of biologic therapy and facilitating a treat-to-target approach is unknown. AIM: To evaluate clinical and process-driven outcomes in a virtual clinic compared to standard outpatient care amongst patients receiving intensified anti-TNF therapy for secondary loss of response. METHODS: We performed a retrospective multi-centre, parallel, observational cohort study of Crohn's disease patients receiving intensified anti-TNF therapy for secondary loss of response. Objective assessments of disease activity and anti-TNF trough levels at secondary loss of response and during subsequent 6-month semesters, were compared longitudinally between virtual clinic and standard outpatient care cohorts. The primary endpoint was treatment success, with appropriateness of dose intensification, tight disease monitoring and treatment de-escalation representing secondary outcomes. RESULTS: Of 149 patients with similar baseline characteristics, 69 were managed via a virtual clinic and 80 via standard outpatient care. There were higher rates of treatment success in the virtual clinic cohort (60.9 vs 35.0%, P < 0.002). Rates of appropriate dose intensification (82.6% vs 40.0%, P < 0.001), biomarker remission (faecal calprotectin P = 0.002), tight-disease monitoring (84.1% vs 28.8%, P < 0.001) and treatment de-escalation (21.3% vs 10.0%, P = 0.027) also favoured the virtual clinic cohort. CONCLUSION: This study favoured a virtual clinic-led model-of-care over standard outpatient care in facilitating treatment success as part of an effective treat-to-target approach in Crohn's disease. A virtual clinic model-of-care also improved treatment outcomes and quality of use of intensified anti-TNF therapy through processes that promoted appropriate dose intensification and tight-disease monitoring, while encouraging more frequent dose de-escalation.


Assuntos
Assistência Ambulatorial/métodos , Produtos Biológicos/administração & dosagem , Doença de Crohn/tratamento farmacológico , Planejamento de Assistência ao Paciente , Medicina de Precisão/métodos , Telemedicina/métodos , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/normas , Produtos Biológicos/efeitos adversos , Estudos de Coortes , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Tolerância a Medicamentos , Feminino , Humanos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Pessoa de Meia-Idade , Planejamento de Assistência ao Paciente/normas , Medicina de Precisão/normas , Estudos Retrospectivos , Índice de Gravidade de Doença , Padrão de Cuidado , Resultado do Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Fator de Necrose Tumoral alfa/imunologia , Adulto Jovem
13.
Aliment Pharmacol Ther ; 51(11): 1031-1038, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32329532

RESUMO

BACKGROUND: Biologic therapies in patients with Crohn's disease often yield low clinical and endoscopic remission rates. After multiple failed therapies, combining two biologic therapies is possibly the sole medical alternative to recurrent surgery. However, data on this approach are limited. AIMS: To assess the efficacy and safety of concomitant use of two biologic therapies in the largest cohort to date of refractory Crohn's disease patients. METHODS: Data were extracted from Crohn's disease patients started on dual biologic therapy at two referral centres. Biologics utilised include infliximab, adalimumab, vedolizumab, ustekinumab, certolizumab and golimumab. The primary outcome was endoscopic improvement (>50% reduction in Simplified Endoscopic Score-Crohn's disease [SES-CD] or explicitly stated). Endoscopic remission (SES-CD < 3 or stated), clinical response (Crohn's disease-patient-reported outcome-2 score [PRO2] reduced by 8), clinical remission (PRO2 < 8), and C-reactive protein (CRP) were also assessed. RESULTS: A total of 22 patients with 24 therapeutic trials of dual biologic therapy were identified. The majority of patients had prior surgical resections (91%), stricturing (59%) or penetrating (36%) phenotype, and perianal fistulas (50%). Median number of prior failed biologics was 4. Endoscopic improvement occurred in 43% of trials and 26% achieved endoscopic remission. Fifty per cent had clinical response and 41% achieved clinical remission. There were significant post-treatment reductions in median SES-CD (14.0 [12.0-17.5] to 6.0 [2.5-8.0], P = 0.0005], PRO-2 (24.1 [20.3-27.0] to 13.4 [4.6-21.8], P = 0.002] and CRP (17.0 [11.0-24.0] to 9.0 [4.0-14.0], P = 0.02). Presence of perianal fistulas decreased from 50% to 33%. Adverse events occurred in 13% of trials. CONCLUSION: Dual biologic therapy was associated with clinical, biomarker and endoscopic improvements in selected patients with refractory Crohn's disease who failed multiple biologics. Further studies are needed to validate this approach.


Assuntos
Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Doença de Crohn/tratamento farmacológico , Resistência a Medicamentos , Quimioterapia Combinada , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adolescente , Adulto , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Certolizumab Pegol/administração & dosagem , Certolizumab Pegol/efeitos adversos , Estudos de Coortes , Doença de Crohn/diagnóstico por imagem , Doença de Crohn/metabolismo , Resistência a Medicamentos/efeitos dos fármacos , Quimioterapia Combinada/efeitos adversos , Endoscopia Gastrointestinal , Feminino , Fármacos Gastrointestinais/administração & dosagem , Fármacos Gastrointestinais/efeitos adversos , Humanos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Estudos Retrospectivos , Falha de Tratamento , Resultado do Tratamento , Ustekinumab/administração & dosagem , Ustekinumab/efeitos adversos , Adulto Jovem
14.
World Neurosurg ; 139: 260-263, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32247793

RESUMO

BACKGROUND: Adalimumab (Humira) is a recombinant human monoclonal antibody against tumor necrosis factor alpha, which works by blocking the interaction of tumor necrosis factor alpha with its cell-surface receptors, thereby limiting the progression of inflammatory pathways. Its use is approved for several autoimmune conditions, including chronic plaque psoriasis, for which it has been prescribed as a first-line biologic treatment. Increased risks of malignancy, particularly nonmelanoma skin cancer and non-central nervous system lymphomas, have been reported with use of this drug; however, there have been no reports of central nervous system lymphomas. CASE DESCRIPTION: A 43-year-old man presented for evaluation following recent speech difficulty and a generalized tonic-clonic seizure. His medical history was significant for plaque psoriasis, for which he had been receiving treatment with adalimumab for 4 months. Magnetic resonance imaging scan of the brain with contrast agent showed a well-defined rounded enhancing lesion in the left temporal lobe with circumferential vasogenic edema. Mass effect was noted. Computed tomography scan of the chest, abdomen, and pelvis was unremarkable. He underwent excisional biopsy, and the preliminary intraoperative pathology report revealed a diagnosis of high-grade lymphoma. Subsequent analysis of morphology and immunophenotyping was consistent with primary diffuse large B-cell lymphoma of the central nervous system. Use of adalimumab was discontinued. Following combination therapy with high-dose methotrexate and rituximab along with 20 sessions of cranial radiation therapy, the patient was disease-free at 14-month follow-up. CONCLUSIONS: We report the first case to our knowledge showing a possible association of central nervous lymphoma and adalimumab.


Assuntos
Adalimumab/efeitos adversos , Anti-Inflamatórios/efeitos adversos , Neoplasias Encefálicas/induzido quimicamente , Linfoma Difuso de Grandes Células B/induzido quimicamente , Psoríase/tratamento farmacológico , Adulto , Humanos , Masculino
16.
Cochrane Database Syst Rev ; 4: CD012005, 2020 04 16.
Artigo em Inglês | MEDLINE | ID: mdl-32297974

RESUMO

BACKGROUND: Inflammatory bowel disease (IBD) is an umbrella term used to describe a group of chronic, progressive inflammatory disorders of the digestive tract. Crohn's disease and ulcerative colitis are the two main types. Fatigue is a common, debilitating and burdensome symptom experienced by individuals with IBD. The subjective, complex nature of fatigue can often hamper its management. The efficacy and safety of pharmacological or non-pharmacological treatments for fatigue in IBD is not yet established through systematic review of studies. OBJECTIVES: To assess the efficacy and safety of pharmacological and non-pharmacological interventions for managing fatigue in IBD compared to no treatment, placebo or active comparator. SEARCH METHODS: A systematic search of the databases Embase, MEDLINE, Cochrane Library, CINAHL, PsycINFO was undertaken from inception to July 2018. A top-up search was run in October 2019. We also searched the Cochrane IBD Group Specialized Register, the Cochrane Central Register of Controlled Trials, ongoing trials and research registers, conference abstracts and reference lists for potentially eligible studies. SELECTION CRITERIA: Randomised controlled trials of pharmacological and non-pharmacological interventions in children or adults with IBD, where fatigue was assessed as a primary or secondary outcome using a generic or disease-specific fatigue measure, a subscale of a larger quality of life scale or as a single-item measure, were included. DATA COLLECTION AND ANALYSIS: Two authors independently screened search results and four authors extracted and assessed bias independently using the Cochrane 'Risk of bias' tool. The primary outcome was fatigue and the secondary outcomes included quality of life, adverse events (AEs), serious AEs and withdrawal due to AEs. Standard methodological procedures were used. MAIN RESULTS: We included 14 studies (3741 participants): nine trials of pharmacological interventions and five trials of non-pharmacological interventions. Thirty ongoing studies were identified, and five studies are awaiting classification. Data on fatigue were available from nine trials (1344 participants). In only four trials was managing fatigue the primary intention of the intervention (electroacupuncture, physical activity advice, cognitive behavioural therapy and solution-focused therapy). Electroacupuncture Fatigue was measured with Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (scores range from 0 to 52). The FACIT-F score at week eight was 8.00 points higher (better) in participants receiving electroacupuncture compared with no treatment (mean difference (MD) 8.00, 95% CI 6.45 to 9.55; 1 RCT; 27 participants; low-certainty evidence). Results at week 16 could not be calculated. FACIT-F scores were also higher with electroacupuncture compared to sham electroacupuncture at week eight (MD 5.10, 95% CI 3.49 to 6.71; 1 RCT; 30 participants; low-certainty evidence) but not at week 16 (MD 2.60, 95% CI 0.74 to 4.46; 1 RCT; 30 participants; low-certainty evidence). No adverse events were reported, except for one adverse event in the sham electroacupuncture group. Cognitive behavioural therapy (CBT) and solution-focused therapy Compared with a fatigue information leaflet, the effects of CBT on fatigue are very uncertain (Inflammatory Bowel Disease-Fatigue (IBD-F) section I: MD -2.16, 95% CI -6.13 to 1.81; IBD-F section II: MD -21.62, 95% CI -45.02 to 1.78; 1 RCT, 18 participants, very low-certainty evidence). The efficacy of solution-focused therapy on fatigue is also very uncertain, because standard summary data were not reported (1 RCT, 98 participants). Physical activity advice One 2 x 2 factorial trial (45 participants) found physical activity advice may reduce fatigue but the evidence is very uncertain. At week 12, compared to a control group receiving no physical activity advice plus omega 3 capsules, FACIT-F scores were higher (better) in the physical activity advice plus omega 3 group (FACIT-F MD 6.40, 95% CI -1.80 to 14.60, very low-certainty evidence) and the physical activity advice plus placebo group (FACIT-F MD 9.00, 95% CI 1.64 to 16.36, very low-certainty evidence). Adverse events were predominantly gastrointestinal and similar across physical activity groups, although more adverse events were reported in the no physical activity advice plus omega 3 group. Pharmacological interventions Compared with placebo, adalimumab 40 mg, administered every other week ('eow') (only for those known to respond to adalimumab induction therapy), may reduce fatigue in patients with moderately-to-severely active Crohn's disease, but the evidence is very uncertain (FACIT-F MD 4.30, 95% CI 1.75 to 6.85; very low-certainty evidence). The adalimumab 40 mg eow group was less likely to experience serious adverse events (OR 0.56, 95% CI 0.33 to 0.96; 521 participants; moderate-certainty evidence) and withdrawal due to adverse events (OR 0.48, 95%CI 0.26 to 0.87; 521 participants; moderate-certainty evidence). Ferric maltol may result in a slight increase in fatigue, with better SF-36 vitality scores reported in the placebo group compared to the treatment group following 12 weeks of treatment (MD -9.31, 95% CI -17.15 to -1.47; 118 participants; low-certainty evidence). There may be little or no difference in adverse events (OR 0.55, 95% CI 0.26 to 1.18; 120 participants; low-certainty evidence) AUTHORS' CONCLUSIONS: The effects of interventions for the management of fatigue in IBD are uncertain. No firm conclusions regarding the efficacy and safety of interventions can be drawn. Further high-quality studies, with a larger number of participants, are required to assess the potential benefits and harms of therapies. Future studies should assess interventions specifically designed for fatigue management, targeted at selected IBD populations, and measure fatigue as the primary outcome.


Assuntos
Fadiga/terapia , Doenças Inflamatórias Intestinais/complicações , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/efeitos adversos , Terapia Cognitivo-Comportamental , Eletroacupuntura , Exercício Físico , Fadiga/etiologia , Ácidos Graxos Ômega-3/administração & dosagem , Ácidos Graxos Ômega-3/efeitos adversos , Compostos Férricos/efeitos adversos , Hematínicos/efeitos adversos , Humanos , Psicoterapia Breve , Pironas/efeitos adversos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Aliment Pharmacol Ther ; 51(9): 852-860, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32201971

RESUMO

BACKGROUND: Few data exist to help select a second biologic agent in patients with refractory ulcerative colitis (UC). AIM: To compare the efficacy of infliximab (IFX) and vedolizumab (VDZ) in UC patients who failed a first subcutaneous anti-tumor necrosing factor (TNF) agent. METHODS: Consecutive UC patients from 12 French centres starting IFX or VDZ after at least one injection of adalimumab or golimumab have been included in a retrospective study. Outcomes were clinical remission at week 14, survival without treatment discontinuation and survival without UC-related event. RESULTS: Among the 225 patients included, clinical remission at week 14 was achieved in 40/154 (26%) patients treated with IFX and in 35/71 (49%) treated with VDZ (P = 0.001). After a propensity score matching analysis, this difference remained significant (odds ratio: 1.67; 95% confidence interval: 1.08-2.56; P = 0.02). With a median follow-up of 117 weeks, survival rates without treatment discontinuation at years 1 and 3 were 50% and 29% with IFX, and 80% and 55% with VDZ, respectively (P < 0.001). Regarding survival without UC-related event, they were 49% and 27% with IFX, and 74% and 52% with VDZ (P < 0.01). CONCLUSION: After failure of a first subcutaneous anti-TNF agent, UC patients were more likely to achieve clinical remission with VDZ than those treated with IFX. Although due to prescription habits patients in the IFX group had a significantly more severe disease, these differences remained after adjustments and subgroup analyses. Such results have to be confirmed prospectively and warrant dedicated head-to-head trials.


Assuntos
Adalimumab/administração & dosagem , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais/administração & dosagem , Colite Ulcerativa/tratamento farmacológico , Infliximab/uso terapêutico , Adalimumab/efeitos adversos , Adulto , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Fatores Biológicos/administração & dosagem , Fatores Biológicos/efeitos adversos , Estudos de Coortes , Colite Ulcerativa/patologia , Pesquisa Comparativa da Efetividade , Substituição de Medicamentos , Feminino , Humanos , Infliximab/efeitos adversos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Resultado do Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto Jovem
20.
Medicine (Baltimore) ; 99(10): e18954, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32150046

RESUMO

RATIONALE: In patients receiving biological therapies, serious infections are a major concern. Infections associated with anti-tumor necrosis factor antibody therapy include tuberculosis, viral, fungal, and bacterial infections. Likewise, severe infections of the upper and lower respiratory tract, lung, skin and soft tissue, urinary tract, gastrointestinal tract, joint, and bone have also been reported previously. However, infections involving the central nervous system are rare, especially an intracranial infection caused by odontogenic infection. To date, only few cases have been reported of this infection. This is the first case of a patient with psoriatic arthritis receiving adalimumab and developing brain abscess of odontogenic origin. PATIENT CONCERNS: A 39-year-old male with psoriatic arthritis receiving adalimumab treatment came to the emergency department with initial presentation of sudden onset convulsions. He had been receiving adalimumab treatment for 1 month. Two days after the third injection, the patient had an episode of sudden-onset general convulsion for nearly 5 min with the upgazing and general tonic presentation. Magnetic resonance imaging (MRI) showed left frontal lobe brain abscess. Pus culture from the brain abscess detected Streptococcus sanguinis (S. sanguinis), Fusobacterium nucleatum (F. nucleatum), and Parvimonas micra (P. micra). DIAGNOSIS: Brain abscess with odontogenic infection. INTERVENTIONS: The patient received left frontal craniotomy, abscess drainage and systemic empiric antibiotics treatment with vancomycin, cefepime, and metronidazole. Due to drug rash with eosinophilia and systemic symptoms during the treatment, vancomycin and metronidazole were discontinued, and systemic antibiotics were switched to teicoplanin and ceftriaxone. OUTCOMES: A brain MRI follow-up performed after 1 month of initial treatment revealed the reduced size of the abscess lesion and minimal oedema. The patient was discharged with stable condition. LESSONS: To the best of our knowledge, this is the first case of a patient with psoriatic arthritis receiving adalimumab and developing brain abscess of odontogenic origin. Such a rare diagnosis must be kept in mind when patients treated with adalimumab present with sudden-onset convulsions. Careful dental examination should be performed before administration of adalimumab.


Assuntos
Adalimumab/efeitos adversos , Antirreumáticos/efeitos adversos , Artrite Psoriásica/tratamento farmacológico , Abscesso Encefálico/diagnóstico , Cérebro , Adulto , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Abscesso Encefálico/diagnóstico por imagem , Abscesso Encefálico/etiologia , Abscesso Encefálico/microbiologia , Ceftriaxona/administração & dosagem , Ceftriaxona/uso terapêutico , Terapia Combinada , Craniotomia , Diagnóstico Diferencial , Firmicutes/isolamento & purificação , Fusobacterium nucleatum/isolamento & purificação , Humanos , Imagem por Ressonância Magnética , Masculino , Periodontite/complicações , Streptococcus/isolamento & purificação , Streptococcus sanguis , Teicoplanina/administração & dosagem , Teicoplanina/uso terapêutico
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